ST. PETERSBURG — When he ran one of the area's first clinics for AIDS patients, Dr. Bob Wallace dealt with a frustrating dilemma: High price tags were keeping promising new medications out of reach.
More than 25 years later, that's no longer the case for many HIV/AIDS patients in the United States, thanks in part to publicly funded drug-assistance programs. But Wallace, now a part-time Pinellas County Health Department doctor nearing retirement, is watching a similar problem play out again — only this time with hepatitis C patients.
A new drug called Sovaldi has been hailed as a breakthrough in the fight against hepatitis C, a chronic liver disease that kills more people in the United States each year than AIDS. Until now, the standard treatment has cured fewer than half of patients. It, too is costly, but it has such painful side effects that many don't even try it, or can't complete it.
But Sovaldi's eye-popping price — $84,000 for a standard 12-week course — has left insurance companies and state Medicaid directors struggling over how to pay, especially as diagnoses increase. And while uninsured hepatitis C patients may be able to get financial help through the drugmaker, many of them don't even know where to start — not to mention they'd still have to find a specialist willing to see them.
"I call this the big pink elephant in our living room," Wallace said.
The well-publicized controversy over the price has prompted a broader debate over how to handle future blockbuster specialty drugs with similarly high price tags.
An activist group, the AIDS Healthcare Foundation, has asked state Medicaid directors to leave Sovaldi off their lists of approved medications to force drugmaker Gilead Sciences to lower its price. The most expensive AIDS combo drug on the market, the foundation notes, is also manufactured by Gilead but costs $80 per pill — a fraction of the $1,000-a-pill Sovaldi.
And recently, a prominent group of medical experts working with the insurance-affiliated California Technology Assessment Forum called Sovaldi a "low-value" drug, with panelists recommending doctors prescribe the drug first to those who need it most.
"What I really wish for is that we could push back on the price rather than have to make patients wait or be denied,'' Dr. Rena Fox, a professor of medicine at the University of California at San Francisco, said at the meeting. "Since we don't have (that) ability, then we have to decide which patients are the most urgent to be treated now."
But patients don't want to wait until they get worse, said Ryan Clary, executive director of the consumer group National Viral Hepatitis Roundtable. They also may fear spreading the infection.
"It doesn't provide much of an incentive to get tested only to be told the cost (of treatment) is too high," Clary said.
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Hepatitis C, a virus infecting an estimated 2.7 million people in the United States, including 300,000 Floridians, is transmitted through blood. People at the highest risk are intravenous drug users and those who got blood transfusions before 1992. In some cases, patients were infected by unsanitary body piercing or tattoos. In rare cases, hepatitis C can be sexually transmitted.
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Baby boomers are five times more likely than other adults to be infected. That's why the federal Centers for Disease Control and Prevention in 2012 began recommending that all people born between 1945 and 1965 get tested.
Infected people may have no symptoms for decades before the disease starts to damage the liver. Left unchecked, it can lead to cancer or organ failure.
Traditional hepatitis C treatment includes injections of a drug called interferon, lasts 48 weeks and can cause significant flulike side effects, said Dr. Eliot Godofsky, an infectious disease specialist in Bradenton. The cost can be $60,000 to $90,000, according to J. Mario Molina, chief executive officer of insurer Molina Healthcare, which manages Medicaid patients in nearly a dozen states, including Florida.
But because of the side effects and below-50-percent cure rate, few patients try the old treatment. Now, patients and doctors are going to want access to the new drug, Molina said.
While he believes Medicaid insurers will take a disproportionate hit, many hepatitis C patients have no access to any health insurance.
Government researchers say these patients are most likely to be middle-aged men with low incomes. They can't afford private insurance, they're too young for Medicare, and they don't typically qualify for Medicaid in states like Florida that refused federal funds to expand eligibility for the insurance program for the poor.
Bruce Lee, 53, of St. Petersburg was diagnosed with hepatitis C five years ago. Uninsured and out of work, he went to the Pinellas Health Department, only to learn doctors there could not treat hepatitis C patients. He was referred to a support group.
"We're kind of lost," Lee said.
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Gilead has begun advertising Sovaldi directly to consumers. The drug's cost reflects the investment in getting it to market, a spokeswoman said.
Besides, she noted, the alternatives, such as cancer treatment or organ transplantation, are far more expensive.
"It's important to think about the cost of a cure in the context of the cost of failed therapy or the downstream costs of liver cancer,'' spokeswoman Cara Miller said.
Godofsky, the Bradenton infectious disease specialist, noted Gilead has a limited time to make its money on Sovaldi before competing drugs enter the market.
"Competition tends to bring the prices down," he said. "The pace of new drugs for hepatitis C is developing very, very rapidly."
Private insurers are paying for Sovaldi in certain cases. Florida Blue, for instance, says it pays based on whether the patients meet new clinical guidelines. Godofsky, who has put more than 30 patients on Sovaldi since January, said, "our track record getting (insurers) to pay has been very good."
But as demand grows, the cost of the drug could be too much for many insurers, especially in Medicaid managed-care programs, Molina said. He has asked states, including Florida, to reimburse Medicaid insurers for Sovaldi patients separately this year since the cost of the drug was not built into the contracts.
Medicare, the federal program for seniors, likely will soon start to feel the pressure too as more baby boomers age into the program, Clary said.
Lee, the St. Petersburg man with hepatitis C, said he can't conceive of getting the expensive new drug when he couldn't even get the old one. So he's looking forward to a new health clinic for lower-income people that Dr. Wallace, whom he met at the county Health Department, wants to open.
Wallace hopes to help patients like Lee get into clinical trials or other programs to pay for care. Lee has been suffering increasing bouts of chills, nausea and exhaustion, but like others in his predicament, can find no relief.
"There's just not much for us," he said.
Jodie Tillman can be reached at firstname.lastname@example.org or (813) 226-3374.